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Clinical trials of medicines and medical devices


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Clinical trials of medicines and medical devices

Clinical studies that look at investigating the effects of drugs or medical devices are subject to UK and EU law.

They are regulated in the UK by the Medicines and Healthcare Products Regulatory Agency (MHRA) and require NHS ethics approval before the study can start through the Health Research Authority (HRA)

Clinical investigation of an investigational medicinal product

A clinical trial of an investigational medicinal product (eg an investigation in human subjects, other than a non-interventional trial) usually seeks to:

  1. discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more medicinal products;
  2. identify any adverse reactions;
  3. study absorption, distribution, metabolism and excretion, with the object of ascertaining the safety and/or efficacy of those products.

You can find more advice by visiting the National Institute for Health Research’s Clinical Trials Toolkit.

This type of research will require prior approval from the University, the MHRA and the HRA.

Clinical investigation of a medical device

A clinical investigation of a medical device usually involves any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

  • diagnosis, prevention, monitoring, treatment or alleviation of disease;
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
  • investigation, replacement or modification of the anatomy or of a physiological process;
  • control of conception

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

Visit the GOV.UK website for information on notifying the MHRA about a clinical investigation for a medical device.

This type of research will require prior approval from the University, the MHRA and the HRA.

Staff who are considering carrying out research that will involve a medicine or involve the use of a medical device must seek guidance from the MHRA